CQV Engineer - OT & Software Validation (GMP/CSV)

Evote; Toulouse; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Evotec Toulouse, part of the Sandoz acquisition, invites you to join the MS&T CQV team to manage qualification activities for automation and software driving manufacturing systems.

You will define qualification strategies, produce IQ/OQ/PQ documents, review specifications, and maintain the validated state with ALCOA+ data integrity, supporting inspections and audits. Fluent English and French preferred; fixed-term 12-month on-site role.

Qualifications

• Degree in Automation, Industrial IT, Process Engineering, or a related field.
• Experience in qualification/validation activities in a regulated industrial environment is preferred.
• Knowledge of GMP, CSV regulations (EU GMP Annex 11, 21 CFR Part 11), and GAMP 5 methodologies.

Responsabilités

• Define qualification/validation strategies per internal procedures.
• Create and maintain qualification/validation documents (IQ/OQ/PQ, plans, reports, traceability).
• Review specifications (URS, FS, HDS, FDS), FAT, SAT.
• Manage change controls, deviations, CAPA within OT/software scope.
• Maintain the validated state and ensure data integrity (ALCOA+).
• Support regulatory inspections and customer audits.

Connaissances

GMP

CSV

Risk Management

Data Integrity (ALCOA+)

Change Control

Deviations & CAPA

Technical Documentation

Cross-Functional Collaboration

Technical Writing

Languages (English & French)

Formation

Degree in Automation/Industrial IT/Process Engineering

Outils

PLC

SCADA

HMI

Description du poste

Evotec Toulouse, part of the Sandoz acquisition, invites you to join the MS&T CQV team to manage qualification activities for automation and software driving manufacturing systems.

You will define qualification strategies, produce IQ/OQ/PQ documents, review specifications, and maintain the validated state with ALCOA+ data integrity, supporting inspections and audits. Fluent English and French preferred; fixed-term 12-month on-site role.